In December 2013, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released its report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The report outlines the types of findings that can arise from various tests and procedures in a variety of contexts, and makes 17 recommendations for the ethical and professional management of such findings.
This primer was designed to help institutional review boards (IRBs) understand and implement the Bioethics Commission’s recommendations regarding how to manage incidental and secondary findings ethically in the research setting. IRB members can use it to improve their understanding of the Bioethics Commission’s recommendations and consider how to ensure the ethical management of incidental and secondary findings that could arise in the protocols they review.
Download primer for IRB Members here.